COVID-19 Vaccine Trial Appointment Instructions

This website is a resource for research candidates who have scheduled an enrollment appointment for the Ensemble 2 Covid-19 Vaccine Trial at the University of Chicago Vaccine Trial Trailers.

To prepare for your appointment, please read the following instructions thoroughly.

Study Overview

The purpose of this Johnson & Johnson clinical research study is to determine the safety and efficacy (whether it works) of a two-dose regimen of an investigational vaccine for the prevention of COVID-19. This investigational vaccine is being evaluated in people 18 years of age or older. If you qualify, you will be randomly assigned by chance (like flipping a coin) to 1 of 2 groups within the study. Depending on which group you are assigned, you will receive either investigational vaccine or placebo. In this study all participants will receive 2 injections, approximately 2 months apart. Some participants will receive 2 injections of Ad26.COV2.S vaccine and others will receive 2 injections of placebo.

Four Important Points

• This is a clinical trial to test a COVID-19 vaccine
• This study is not the same as a vaccination program, and there is a 50% chance that you will not receive the vaccine as part of the study
• If you have already received a COVID-19 vaccine or are participating in another COVID-19 vaccine trial, you are not eligible to participate in this study
• Eligibility criteria change weekly and with little notice, and unfortunately it is possible that your appointment will be cancelled or have to be rescheduled

To prepare for your appointment, please review both the general consent form and the emergency use authorization consent form for this clinical trial. Reading these forms will help you to learn about the study and what it involves, and will save time on the day of your appointment. It will also help you to think of questions you might like to ask our staff during your appointment.

You can access the general consent form here: Ensemble 2 Consent Form

You can access the emergency use authorization consent form here: Ensemble 2 EUA_2021_1_22

For the safety of our staff and other research participants, please reschedule your appointment if you are experiencing any of the following on the day of your appointment:

1. You currently have any ONE or more of these symptoms: cough, fever (99.5 or higher), sore throat, new loss of taste or smell, body aches, nasal congestion, runny nose, trouble breathing, nausea, vomiting, or diarrhea
2. You had close contact with anyone who has tested positive for COVID-19 in the last 14 days
3. You have tested positive for COVID-19 in the past 14 days

All research participants are required to wear a mask to their appointment, and are asked to not bring visitors. All participants will be asked COVID-19 screening questions and will have their temperature taken. Please dress in layers for your appointment, as our staff will need to access your arms to take your blood pressure and administer the injection.

Directions & Parking

The UChicago IPPH vaccine research trailers are located at the corner of 55^th St. and S. Drexel Ave. in Hyde Park, next to Ronald McDonald House Charities. When you arrive at the trailers, please proceed to Trailer #1 to check in.

Hourly parking is available on 55^th St. and on other streets in the area, and limited parking is available in a small lot next to the trailers. To access this parking lot from 55^th St., turn north onto S. Ellis Ave. Make an immediate left turn onto 55^th St.  and head west toward Ronald McDonald House. The parking lot is straight ahead, at the corner of 55^th St. and S. Drexel Ave.